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OC-010 Final efficacy and safety in hcv genotype 1-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin: topaz-i results from the united kingdom and ireland
  1. D Forton1,
  2. A Ustianowski2,
  3. R Aspinall3,
  4. S Ryder4,
  5. M Aldersley5,
  6. D Mutimer6,
  7. F Murray7,
  8. PA McCormick8,
  9. J Dillon9,
  10. G Foster10,
  11. K Agarwal11,
  12. M Charafeddine12,
  13. A Joy13,
  14. L Liu13,
  15. R-M Stanica14,
  16. T Pilot-Matias13,
  17. M O’Meara13,
  18. C Pollard13,
  19. DE Cohen13,
  20. S Norris15
  1. 1St. George’s Hospital, London
  2. 2Infectious Diseases and Tropical Medicines Unit, North Manchester General Hospital, Manchester
  3. 3D8 Research Clinic, Queen Alexandra Hospital, Portsmouth
  4. 4Nottingham Digestive Diseases Centre, University Hospital Queen’s Medical Centre, Nottingham
  5. 5St. James University Hospital, Leeds
  6. 6Queen Elizabeth Hospital, University Hospitals Birmingham NHS, Birmingham, UK
  7. 7Hepatology, Beaumont Hospital
  8. 8Liver Unit, St. Vincent’s University Hospital, Dublin, Ireland
  9. 9Ninewells Hospital, Dundee
  10. 10Royal London Hospital, London
  11. 11North Manchester General Hospital, Manchester, UK
  12. 12AbbVie Inc
  13. 13AbbVie, North Chicago, IL
  14. 14AbbVie, North Cicago, IL, USA
  15. 15St James Hospital, Dublin, Ireland

Abstract

Introduction Ombitasvir/paritaprevir*/ritonavir (*identified by AbbVie and Enanta) and dasabuvir (3-DAA) ± ribavirin (RBV) treatment is effective and safe for patients infected with hepatitis C genotype 1 (HCV GT1), including those with compensated cirrhosis. TOPAZ-I, an ongoing global phase 3b trial, assesses the impact of sustained virologic response (HCV RNA

Method The enrolled patients in TOPAZ-I received 3-DAA ± RBV, per label. These pooled, interim results included SVR12, adverse events (AEs), clinical outcomes, and liver stiffness evolution. SVR12 data were analysed using the intent-to-treat (ITT) population (missing data imputed as failures).

Results Among the 126 patients enrolled (table), the ITT SVR12 rate was 98%: one patient relapsed and 2 discontinued study drug prematurely, one due to AEs. AEs occurring in >10% of patients are listed in table. Six patients experienced serious AEs, none related to DAAs. Grade 3 laboratory abnormalities were rare and no Grade 4 abnormalities were reported. Three patients experienced adverse clinical outcomes, none deemed study drug-related: HCC (on treatment), fatal aspiration pneumonia (on treatment), and death from ischaemic heart disease (post-treatment week 18).

Conclusion These regional TOPAZ-I results confirm the efficacy and safety of 3-DAA ± RBV in HCV GT1-infected patients. Adverse clinical outcomes were rare. Liver stiffness changes post-treatment will be presented at the meeting.

Disclosure of Interest D. Forton Conflict with: participated in AbbVie-sponsored research, A. Ustianowski Conflict with: participated in AbbVie-sponsored research, R. Aspinall Conflict with: participated in AbbVie-sponsored research, S. Ryder Conflict with: participated in AbbVie-sponsored research, M. Aldersley Conflict with: participated in AbbVie-sponsored research, D. Mutimer Conflict with: participated in AbbVie-sponsored research, F. Murray Conflict with: participated in AbbVie-sponsored research, P. McCormick Conflict with: participated in AbbVie-sponsored research, J. Dillon Conflict with: participated in AbbVie-sponsored research, G. Foster Conflict with: participated in AbbVie-sponsored research, K. Agarwal Conflict with: participated in AbbVie-sponsored research, M. Charafeddine Conflict with: AbbVie employee and may own company stock, A. Joy Conflict with: AbbVie employee and may own company stock, L. Liu Conflict with: AbbVie employee and may own company stock, R.-M. Stanica Conflict with: AbbVie employee and may own company stock, T. Pilot-Matias Conflict with: AbbVie employee and may own company stock, M. O’Meara Conflict with: AbbVie employee and may own company stock, C. Pollard Conflict with: AbbVie employee and may own company stock, D. Cohen Conflict with: AbbVie employee and may own company stock, S. Norris Conflict with: participated in AbbVie-sponsored research

  • HCV
  • Hepatitis C

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